Don Kellerman, Pharm.D., is an accomplished pharmaceutical executive, clinical development leader, regulatory strategist, and scientific advisor whose career spans more than 35 years across the pharmaceutical and life sciences industries. Throughout his career, Don has helped guide innovative therapies from early development through late-stage clinical programs, regulatory review, and commercialization efforts. His experience encompasses clinical development, regulatory affairs, medical affairs, biostatistics, quality assurance, clinical operations, and strategic planning, giving him a comprehensive perspective on the scientific and organizational challenges that shape successful drug development. He now seeks to bring that depth of experience to organizations where thoughtful board leadership can help management teams navigate complexity, evaluate opportunities, and create meaningful change.
Don’s career has been distinguished by progressively senior leadership responsibilities within established pharmaceutical companies as well as emerging and growth-stage organizations. His executive experience includes leadership roles with Glaxo Wellcome, Inspire Pharmaceuticals, MAP Pharmaceuticals, Allergan, Tonix Pharmaceuticals, Zosano Pharmaceuticals, and other life sciences organizations. Across these environments, he has demonstrated an ability to move comfortably between scientific detail and executive-level strategy, leading multidisciplinary teams while maintaining a clear focus on patients, regulatory requirements, organizational priorities, and long-term value creation.
A defining component of Don’s professional expertise is his extensive experience in clinical development and regulatory affairs. Over the course of his career, he has led project teams across the drug-development continuum, from molecule selection and early clinical strategy through pivotal studies and New Drug Application submissions. His work has contributed to programs associated with eight NDAs across four FDA divisions. His experience includes direct interactions with regulatory authorities, development of clinical and regulatory strategies, preparation of major submission components, management of Phase 3 programs, and service as a primary point of contact with the FDA during regulatory review.
At Inspire Pharmaceuticals, Don served as Senior Vice President of Development after initially joining as Vice President of Development. In this capacity, he directed teams responsible for clinical research, regulatory affairs, biostatistics, and pharmaceutical development while overseeing clinical trials conducted across more than 200 sites. He supervised teams of up to 30 full-time and contract professionals, managed budgets reaching $29 million, and oversaw multiple clinical programs across respiratory, ophthalmology, and cardiovascular therapeutic areas. His responsibilities also extended into strategic planning, licensing activities, drug discovery initiatives, and senior corporate leadership, reinforcing the broad business perspective he brings to advisory and board-level discussions.
Don later served as Senior Vice President of Clinical Development and Medical Affairs at MAP Pharmaceuticals, where he oversaw clinical programs and led functions spanning regulatory and quality compliance, biostatistics, and medical affairs. He contributed extensively to NDA preparation, managed Phase 3 trials, and served as a principal FDA contact during the NDA review process. Following Allergan’s acquisition of MAP, Don remained with the organization to help lead the site transition. He subsequently served as Senior Vice President of Clinical Development and Regulatory Affairs at Tonix Pharmaceuticals and as Vice President of Clinical Development at Zosano Pharmaceuticals, continuing to apply his expertise to complex clinical programs, regulatory interactions, scientific communications, and organizational leadership.
Earlier in his career, Don spent more than a decade with Glaxo Wellcome in positions of increasing responsibility spanning cardiovascular development, respiratory clinical research, global clinical research, and U.S. medical affairs. Among his responsibilities, he directed clinical development for Flovent from IND through NDA, led an NDA clinical defense team, and served as the primary presenter at an FDA Pulmonary Advisory Committee meeting. He also participated in global clinical-process redesign, working across international teams and drawing upon input from hundreds of employees, vendors, and clinicians in multiple countries. Experiences such as these gave Don valuable international exposure, including professional engagement involving markets and colleagues in locations such as London and Japan.
In addition to his corporate leadership, Don has developed a substantial record of scientific scholarship and industry thought leadership. He reports approximately 90 publications and four patents, reflecting decades of engagement with pharmaceutical research, clinical pharmacology, respiratory medicine, migraine therapeutics, drug delivery, and clinical-trial methodology. His published work includes research and reviews involving inhaled therapies, migraine treatments, pharmacokinetics, clinical endpoints, and novel delivery technologies. He has also participated in several international conferences and scientific speaking engagements, demonstrating an ability to translate complex scientific and clinical concepts for professional audiences. His continued publication activity, including coauthorship of a 2024 review examining the pharmacology of dihydroergotamine in migraine, further demonstrates his sustained engagement with scientific advancement.
Don holds both a Doctor of Pharmacy and a Bachelor of Science from the University of Minnesota College of Pharmacy. His formal scientific education, combined with decades of executive experience, has enabled him to approach pharmaceutical development through both rigorous clinical analysis and practical business judgment. His expertise encompasses clinical development, regulatory strategy and FDA interactions, clinical trials, medical affairs, clinical research, pharmaceutical development, GCP, cross-functional leadership, strategic planning, and multiple therapeutic areas. Today, as a clinical development consultant, he continues to advise organizations on clinical trials and regulatory submissions, extending the knowledge accumulated throughout his operating career to companies facing critical development decisions.
Board and advisory service represent a natural extension of Don’s professional journey. Having previously experienced board participation with a smaller company, he saw firsthand how informed governance and experienced perspectives can help an organization pursue constructive change. He remains motivated by the belief that decades of pharmaceutical leadership still have significant value to offer organizations confronting scientific, regulatory, operational, and strategic challenges. Rather than viewing experience simply as a record of past accomplishments, Don sees it as a resource that can be applied to the next generation of companies, executives, therapies, and patients.
Beyond his professional accomplishments, Don brings a personal dimension grounded in creativity, curiosity, and an appreciation for collaboration. He enjoys guitar, vocals, and classic rock, interests that provide a meaningful counterbalance to a career built around science, regulation, and organizational leadership. Whether contributing to a clinical-development strategy, advising an executive team, evaluating a regulatory pathway, or participating in a board discussion, his approach reflects a desire to contribute constructively and use accumulated knowledge in service of progress. His career demonstrates that meaningful leadership is not simply about possessing expertise; it is about knowing when and how to apply that expertise so that organizations and the people within them can make better decisions.
Character:
Don brings a strong sense of professional responsibility developed through decades of leadership in highly regulated environments where sound judgment, scientific integrity, and accountability are essential. His continuing desire to contribute through consulting and board service reflects a commitment to using his experience to help organizations and their leaders create meaningful, positive change.
Knowledge:
He combines more than 35 years of pharmaceutical experience with deep expertise in clinical development, regulatory affairs, FDA interactions, medical affairs, clinical research, and drug-development strategy. His extensive publication record, patent activity, and experience across numerous clinical programs give him a broad scientific foundation from which to evaluate complex opportunities and challenges.
Strategic:
Don understands how to connect scientific and clinical decisions with regulatory requirements, organizational capabilities, development timelines, and broader corporate objectives. Having managed multidisciplinary teams, substantial budgets, pivotal clinical programs, regulatory submissions, licensing activities, and development portfolios, he can bring a multidimensional perspective to strategic and board-level decision-making.
Communication:
Communicating complex scientific and regulatory matters to regulators, corporate leaders, boards, investors, key opinion leaders, clinical teams, and international scientific audiences throughout his career. His experience presenting before an FDA advisory committee, participating in international conferences, authoring scientific publications, and leading cross-functional teams demonstrates an ability to make sophisticated information understandable, relevant, and actionable.
